| CTRI Number |
CTRI/2025/07/091168 [Registered on: 18/07/2025] Trial Registered Prospectively |
| Last Modified On: |
16/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Using coronary calcium scores to predict heart disease: Comparing this simple scan with traditional angiograms in people with and without symptoms |
|
Scientific Title of Study
|
Assessing coronary calcium score as a non-invasive predictor of coronary artery disease severity: A comparative analysis with angiography in symptomatic and asymptomatic populations |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashwathi A K |
| Designation |
DrNB Trainee |
| Affiliation |
Narayana Multispeciality Hospital, Mysore |
| Address |
CAH/1, 3rd Phase, Devanur 2nd Stage , R.S.Naidu Nagar
Mysore KARNATAKA 570019 India |
| Phone |
9791791978 |
| Fax |
|
| Email |
ashwathipradeep@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Keshavamurthy V |
| Designation |
Cardiology HOD |
| Affiliation |
Narayana Multispeciality Hospital, Mysore |
| Address |
CAH/1, 3rd Phase, Devanur 2nd Stage , R.S.Naidu Nagar
Mysore KARNATAKA 570019 India |
| Phone |
9791791978 |
| Fax |
|
| Email |
keshava.murthy.dr01@narayanahealth.org |
|
Details of Contact Person Public Query
|
| Name |
Ashwathi A K |
| Designation |
DrNB Trainee |
| Affiliation |
Narayana Multispeciality Hospital, Mysore |
| Address |
CAH/1, 3rd Phase, Devanur 2nd Stage , R.S.Naidu Nagar
Mysore KARNATAKA 570019 India |
| Phone |
9791791978 |
| Fax |
|
| Email |
ashwathipradeep@gmail.com |
|
|
Source of Monetary or Material Support
|
| Narayana Multispeciality Hospital, CAH/1, 3rd Phase, Devanur 2nd Stage , R.S.Naidu Nagar Mysore, Karnataka, India 570019 |
|
|
Primary Sponsor
|
| Name |
Ashwathi A K |
| Address |
Narayana Multispeciality Hospital, CAH/1, 3rd Phase, Devanur 2nd Stage , R.S.Naidu Nagar Mysore, Karnataka - 570019 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ashwathi A K |
Narayana Multispeciality Hospital |
CAH/1, 3rd Phase, Devanur 2nd Stage , R.S.Naidu Nagar Mysore KARNATAKA |
9791791978
ashwathipradeep@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Narayana Health Academic Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Presenting with symptoms of cardiac ischemia or asymptomatic individuals identified as high risk based on cardiovascular risk scores |
|
| ExclusionCriteria |
| Details |
history of coronary revascularisation/ myocardial infarction/severe renal impairment/critically ill patients/pregnancy or lactation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the reliability of coronary artery calcium score to predict coronary artery disease |
To assess the reliability of coronary artery calcium score to predict coronary artery disease |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compare calcium scores with angiographic findings |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="500" Sample Size from India="500"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Coronary artery disease is a major global health concern, contributing significantly to morbidity and mortality due to the build up of atherosclerotic plaque in the coronary arteries. Although coronary angiography remains the gold standard for diagnosing CAD, its invasive nature and associated risks limit its widespread use. Coronary Artery Calcium scoring, a non-invasive technique utilizing ECG gated CT, provides a safer and more cost effective approach to quantifying calcified plaque and assessing atherosclerotic burden. However, its inability to detect non-calcified plaques and challenges in monitoring disease progression, particularly in patients on statin therapy, underscore the necessity for further investigation. This study seeks to validate CAC scoring as a reliable alternative to coronary angiography, improving CAD diagnosis and management, particularly in underserved populations. By addressing its current limitations and incorporating emerging technologies, CAC scoring has the potential to revolutionize cardiovascular care and enhance patient outcomes. |